Primary Hyperparathyroidism: Does a Systematic Treatment Improve the Calcium and Bone Metabolism After Surgery?

Medical University of Vienna

Status and phase: Unknown; Phase 2

Conditions: Primary Hyperparathyroidism; Bone Metabolism

Treatments: Drug: Calcium and vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT00973336

PHPT02_2008

Details and patient eligibility

About

Primary Hyperparathyroidism (pHPT) increases bone turnover and resorption and thus calcium efflux out of bone. After successful surgical treatment of pHPT, bone takes up calcium again which may result in secondary hyperparathyroidism or even "hungry bone syndrome". Until today there are no studies about this problem helping to develop recommendations or guidelines how to prevent these symptoms.

Study hypothesis: Calcium and vitamin D intake after surgery for PHPT protects the bone by keeping PTH in the normal range (less secondary, reactive hyperparathyroidism), prevents hungry bone- syndrome and improve bone-turnover markers (osteoporosis protection).

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Postmenopausal women
• Male patients
• Biochemically proven PHPT, PTX planned
• No evidence for osteoporosis

Exclusion criteria

• Postoperative hypocalcemia needing substitution with calcium and vitamin D/ 1-25-OH-Vitamin D
• Cancer (lung, breast, prostatic, parathyroid cancer and thyroid carcinoma >1cm)
• Persisting or recurrent PHPT (postoperative hypercalcemia)
• Four-gland hyperplasia
• Multiple endocrine neoplasia (MEN) or hereditary PHPT
• Familial hypercalciuric hypercalcaemia (Ca/creatinine ratio < 0.01)
• Phenylketonuria
• Renal impairment (creatinine clearance <30ml/h)
• Severe hepatic disorder
• Severe systemic disorder
• Thyroid dysfunction
• Immobilisation
• Intake of drugs with potential effects on BMD like glucocorticoids, lithium, estrogen-replacement therapy, selective Estrogen-receptor modulators (sERMs), bisphosphonates in the last three months
• Intake of drugs containing digoxin or digitoxin
• Known allergy against any component of the study medication

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Calcium and vitamin D

Experimental group

Description:

Intervention

Treatment:

Drug: Calcium and vitamin D

No treatment (control)

No Intervention group